Events

Recall of PPC masks

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Fisher and Paykel Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2006-12-12
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-masques-ppc-de-la-societe-fisher-et-paykel-healhcare
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Extra notes in the data
  • Action
    The company Fisher and Paykel Healthcare withdrew from the market on December 8, 2006 the lots of references specified in the appendix of the medical device called "CPAP masks" used for sleep apnea due to a risk of breakage of the teeth located on the connector. Masks made since April 2006 have toothless connectors. The company has directly notified the recipients (health facilities and home care providers) of the incriminated lots with the attached message (12/12/2006) (123 KB) validated by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

PPC masks

Manufacturer

Fisher and Paykel Healthcare
  • Source
    LAANSM